[Drug and Device Law] Thumbs Up - The Ten Best Prescription Drug/Medical Device Decisions of 2014
We at the DDLaw blog wish all our readers a Happy New Year as 2014 recedes inexorably into our rear-view mirror. We hope that your 2014 was pleasant and (if you’re on our side of the “v.”) prosperous. We’re celebrating the new year in our usual style, with our annual top ten best prescription medical product liability litigation decisions of 2014. Some people don’t need an excuse to throw a party. We have many excuses here, and we’re going to tell you about a lot of them in this post.
So, to the envelopes please – we present to you our picks for the ten best judicial decisions of 2014 (and ten more honorable mentions) involving drugs, medical devices, and (if there were any) vaccines. We do limit ourselves to drug/device litigation, as well FDA-related cases raising similar issues. That’s why you won’t find on our list the Supreme Court’s personal jurisdiction decision in Daimler AG v. Bauman, ___ U.S. ___, 134 S. Ct. 746 (2014), even though it might end up having greater beneficial impact on drug/device mass torts than any decision we list below. Cars are simply too far afield, so even for a United States Supreme Court decision, we won’t dilute the drug/device nature of our list that much.
1. In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917 (6th Cir. 2014). The Sixth Circuit addressed one of the most significant issues of current prescription medical product liability, innovator liability, under the laws of no fewer than 22 states. The court predicted that none of the 22 states (for some reason there’s not an appendix discussion of Louisiana) would adopt innovator liability. That’s the biggest wipe out of innovator liability since Conte (2008 #-1) was decided back in 2008. Given how dangerous this theory could become if it ever obtained widespread traction, the number of states involved, and the lack of anything adverse in the opinion, we rank Darvocet as this year’s number one best opinion. The unanimous opinion recites all the familiar reasons why it’s not a good idea to shift liability for 80% of the prescription drugs sold today onto the backs of the 20% market share still maintained by innovator manufacturers – who received no economic benefit, and had no control over, the production and sale of generic drugs. We lauded Darvocet here, and discussed it in more depth here .
2. Caldwell v. Janssen Pharmaceutica, Inc., 144 So.3d 898 (La. 2014). Contingent fee lawyers, under contract to the Louisiana state AG (“aspiring governor”), obtained a $330 million verdict under three state statutes claiming that the defendant’s marketing defrauded various state benefit programs. As we thought it might, the Louisiana Supreme Court reversed, and ordered entry of judgment for the defendants. That is, “go away and take nothing.” It seems that the AG had overlooked one tiny – OK, not so tiny – thing in presenting the state’s case. There was utterly no evidence of fraud, zero evidence of misrepresentation, nor a scrap of proof that any prescribing doctor (it was a prescription drug, after all) relied on the non-existent misrepresentations. The statutes required “fraud” or “false statements,” so the court enforced their express terms, finding the AG’s looser constructions “absurd.” It rejected the same sort of generalized proof that characterized last year’s (2013 #-1) awful Neurontin trilogy. Causation necessarily ran through the prescribing physicians, and the AG didn’t even offer such evidence. So much for contingent fee counsel litigating on the cheap. We hailed the Louisiana Supreme Court’s sanity here.
3. Huck v. Wyeth, Inc., 850 N.W.2d 353 (Iowa 2014). Huck is the first state supreme court opinion rejecting innovator liability. Parallelism would have had us list Huck number one, given last week’s designation of Weeks (the first supreme court going the other way) as our worst opinion. So why not? Two reasons: First, Huck allowed “duty to update” liability against generic manufacturers. While those are rather bad claims (for the reasons discussed here), they’re still claims, so that’s one drawback. Second, Huck might be a plurality opinion, although it gives no such indication. Otherwise, Huck is refreshingly strong stuff. It joins an “overwhelming” majority of appellate courts to reaffirm the “well-settled” rule that product liability lies only against those involved in the manufacture and sale of products. Huck follows Restatement (Third) of Torts, Products Liability §7 as to negligent misrepresentation. Cases like Weeks and Conte are “outliers.” Huck even used a car analogy similar to the one we used in describing the potentially vast scope of non-manufacture liability. We celebrated Huck here.
4. Corber v. Xanodyne Pharmaceuticals, Inc., 771 F.3d 1218 (9th Cir. 2014) (en banc). Corber eliminated what had once seemed like an emerging circuit split on a critical CAFA (Class Action Fairness Act) removal issue. Plaintiffs’ counsel had filed dozens of misjoined complaints, each with at least one non-diverse plaintiff and all with just under the 100 plaintiffs that would have triggered CAFA’s “mass action” removal provision. All these actions – many hundreds of plaintiffs – were filed in various California state trial courts. Compared to this type of gamesmanship, removal before service is bush league. Then plaintiffs took their gaming the system one step too far. They sought “coordination.” Bang! Defendants removed under CAFA. Corber, contrary to a Ninth Circuit panel, held that these removals were proper. Such coordination necessarily embraced some form of joint trials, so the requirements of CAFA were satisfied. An express request for a joint trial isn’t necessary. Since there isn’t any form of coordination in California, except for all purposes, Corber goes a long way to eliminating this practice in the nation’s largest state. We extolled Corber here.
5. Drager v. PLIVA USA, Inc., 741 F.3d 470 (4th Cir. 2014). We consider this the best generic preemption decision of 2014. Other decisions did what Drager did, but Drager did it first. The biggest potential leftover issue from Bartlett/Mensing was the Court’s reluctance to explicitly extend its design defect holding to formulations of design defect other than risk utility. Other formulations exist, most notably “consumer expectation,” but also “absolute liability” (which no jurisdiction actually has) and anarchy (Missouri). We looked at things differently: with warning and design changes preempted, and plaintiffs unable to argue withdrawal from the market, in 99% of the cases, there’s nothing else left. We put a district court case (Fosamax) in our honorable mentions last year (2014 #+20) simply for recognizing this. Then Drager comes along and looks at generic preemption our way. Design defect is out. There is no material (to preemption) difference among the different design defect formulations because no matter what, relief predicated on a change in design is preempted. Subsequent courts have followed Drager, thus eliminating the sort of plaintiff-side salami-slicing that went before. That’s not all. Drager had more goodies for the defense: Express warranty claims are preempted, because they would require label changes. Opposition to fraud preemption is “frivolous.” Maryland doesn’t recognize duty to test or implied warranty in the context of prescription drugs. We gave Drager our stamp of approval here.
6. Ortho-McNeil-Janssen Pharmaceutical, Inc. v. State, 432 S.W.3d 563 (Ark. 2014). Another contingent fee-driven state AG action bites the dust, this one having yielded a $1.2 billion verdict. An FDA warning letter does not create a false claim under that (or, we’d like to think any) state’s statute. This one ranks somewhat lower than Caldwell – even though the verdict was larger – because the rationale for overturning the verdict (and the AG’s theory) is somewhat peculiar, based partially on a codification error. However, the court also held that the warning letter at the center of the AG’s claim was inadmissible as evidence because it was hearsay, and its presence was extremely prejudicial, since the state waved it around throughout the trial. We blew that Arkansas Supreme Court a kiss, here.
7. Booker v. Johnson & Johnson, ___ F. Supp.3d ___, 2014 WL 5113305 (N.D. Ohio Oct. 10, 2014). This is a case we had been waiting for. There’s good language in Bartlett (2013 #+1) that prior FDA approval is required for any design changes to both innovator and generic drugs. The logical import of that language is that design defect claims involving all prescription drugs, innovator as well as generic, should be barred by “impossibility” preemption. That’s exactly what Booker held, evaluating a Georgia-law claim in the Ortho-Evra MDL. We don’t ordinarily run “breaking news” posts about trial-court opinions, but Booker merited it. We broke the news here.
8. Bowerman v. Takeda Pharmaceuticals U.S.A., 442 S.W.3d 839 (Ark. 2014). Two cases from Arkansas! In this one, the Arkansas Supreme Court shot down an Actos plaintiff’s attempt to create a new cause of action for “illegal exaction.” This would have allowed any taxpayer to sue over state reimbursement of prescriptions of any prescription medical product that the taxpayer-plaintiff claimed was “defective.” The mischief that could have caused is obvious. It didn’t happen. A unanimous court held that this claim was bogus. Prescribing an FDA-approved drug was not “unlawful,” nor was state reimbursement of such prescriptions. Indeed, the state could not refuse to pay for properly prescribed drugs. Nor, because the drugs were prescribed, could reimbursement be considered “arbitrary.” We spread the good news here.
9. Martin v. Medtronic, Inc., ___ F. Supp.3d ___, 2014 WL 36352921 (D. Ariz. July 23, 2014) and ___ F. Supp.3d ___, 2014 WL 6633540 (D. Ariz. Nov. 24, 2013) (two related opinions). Just as it was hard to say what was the worst InFuse case of the year, it’s also hard to determine which of these decisions was the best. We’ve settled on the Martin case for several reasons: (1) the result is a complete dismissal, which is pretty basic; (2) the discussion is quite thorough without becoming tedious; (3) the court applies to parallel claims our preferred “narrow gap” view of the intersection between express and implied preemption; (4) Martin rejects the Ramirez (2013 #-9) case from the same judicial district (Arizona); and (5) these decisions correctly recognize “off-label promotion” as a purely federal concept with no state equivalent. The only claims that survive preemption are those alleging false off-label promotion and (because Martin was bound by Stengel (2013 #-2)), inadequate reporting. Both of those claims are TwIqballed, and as to the reporting claim, Martin specifies that the plaintiff has to plead causation, which even Stengel recognized wouldn’t be easy. It wasn’t. Plaintiffs couldn’t carry it off, so their failure to report claim was dismissed by the second Martin opinion. Martin II is the best post-Stengel opinion on adverse event reporting and causation that we’ve seen. That opinion is also useful for prohibiting false off-label promotion claims not specific to the plaintiff’s prescriber as “fraud on the market” theories. We expressed are satisfaction with the first Martin opinion here.
10. Shannon v. Fusco, 89 A.3d 1156 (Md. 2014). Shannon was decided by a state high court, but it’s a narrower issue than the others above. The issue was one of our long-time pet peeves – informed consent claims against prescribing doctors alleging liability for failure to inform patients that a particular use was off-label. Ignoring overwhelming authority, an intermediate Maryland court had allowed the theory. The Maryland Court of Appeals squashed that in no uncertain terms. To physicians in informed consent cases, FDA regulatory status is not a risk, not a benefit, nor even “other pertinent information.” The practical implication of Shannon, and other cases so holding, is that with such allegations not a basis for physician liability, physicians won’t be pointing the finger at our clients over FDA-related information. We blogged about Shannon here.
That’s it for our top ten, but the good news just kept coming in 2014. We want to give shoutouts to more favorable decisions that didn’t crack our top ten. YO!
Here are our Honorable Mentions: (11) Lashley v. Pfizer, Inc., 750 F.3d 470 (5th Cir. 2014) (discussed here) – The best “one-two punch” case, that is generic preemption and no innovator liability, of the year. What raised it above others was its holding that the “parallel claims” exception to express PMA preemption has no place in implied preemption; (12) Tyree v. Boston Scientific Corp., ___ F. Supp.3d ___, 2014 WL 5431993 (S.D.W. Va. Oct. 23, 2014) (discussed here) – We’ve always hated West Virginia’s unique rejection of the learned intermediary rule. Karl was the worst case in our inaugural list back in 2007. Tyree removed medical devices and drugs not marketed direct-to-consumer from Karl’s scope. Let’s hope those limits stick; (13) Chapman v. Procter & Gamble Distributing, LLC, 766 F.3d 1296 (11th Cir. 2014) (discussed here) – An excellent Daubert opinion excluding expert opinions on both general and specific causation); (14) United States ex rel. Rostholder v. Omnicare, Inc., 745 F.3d 694 (4th Cir. 2014) (discussed here) dynamite FCA case rejecting theories that would make mere FDCA violations (here, of GMPs) into a false claim, without much more; (15) Thompson v. Allergan USA, Inc., 993 F. Supp.2d 1007 (E.D. Mo. 2014) (discussed here) – The goal is to move Bartlett/Mensing preemption beyond generic drugs. Thompson did so, holding a dosage-related consumer fraud claim preempted against an innovator drug because that required prior FDA approval; (16) Mack v. Stryker Corp., 748 F.3d 845 (8th Cir. 2014) (discussed here) − Useful decision on state of the art in a pain-pump case. It considered and flatly rejected an adverse decision from another circuit; (17) Public Citizen v. HHS, ___ F. Supp.3d ___, 2014 WL 4388062 (D.D.C. Sept. 5, 2014) (discussed here) – Plaintiffs can’t use FOIA to obtain reportable event summaries, disclosure log summaries, and descriptions of the content of detailing sessions that a manufacturer was required to fill under a corporate integrity agreement; (18) In re Fosamax (Alendronate Sodium) Products Liability Litigation (No. II), 751 F.3d 150 (3d Cir. 2014) (discussed here) – A complete generic preemption win that was particularly welcome after last year’s bad Pa. intermediate appellate decisions (2013 #-4); (19) Locke v. Ethicon Inc., ___ F. Supp.3d ___, 2014 WL 5819824 (S.D. Tex. Nov. 10, 2014) (discussed here) – Important post-Bauman showing “how to” eliminate non-diverse plaintiffs who can’t obtain personal jurisdiction over “their” defendants while avoiding fraudulent joinder/misjoinder problems; (20) Seavey v. Globus Medical, Inc., 2014 WL 1876957 (D.N.J. March 11, 2014) (discussed here) – This decision combines lots of valuable language about off-label use and promotion, with a great result on causation.
Looking over our 2013 lists, nothing’s changed – for better or worse – on our bottom ten from last year, except for Weeks, which did the same (bad) thing after reargument. The United States Supreme Court passed on both the Neurontin cases and Stengel. The Pennsylvania Supreme Court denied an appeal in the Reglan generic preemption cases, so they go back to square one (unless the U.S. Supreme Court intervenes). Still, with the law being what it is, those are nuisance cases. Still, look for lots of them in Philadelphia.
Ditto for our 2013 top ten list. They’re unchanged. As discussed last week, we did lose our #17 honorable mention, Payne, to reversal.
Looking farther back, the Caldwell case we discussed above reversed our #2 bad case from 2012, meaning that the worst two from that year are both gone, which is a first. Whitener (2012 #-7) while not formally reversed, died in the wake of Bartlett in 2014. See Whitener v. PLIVA, Inc., 2014 WL 1276489 (E.D. La. March 27, 2014). On the good side, POM Wonderful (2012 #+8) was reversed by the Supreme Court, but not on preemption or primary jurisdiction grounds, so not much seems to have been lost.
Looking ahead, the Caplinger (2013 #+9) appeal in the Tenth Circuit remains pending, so that one’s still at risk. There will certainly be an appeal in the Actos MDL of the decisions there that made our 2014 bottom ten list. The California Supreme Court in Bristol-Myers-Squibb will rule on personal jurisdiction post-Bauman, with an eventual appeal to the United States Supreme Court likely regardless of the result. Generic preemption remains pending before the United States Supreme Court in Teva Pharmaceuticals USA, Inc. v. Superior Court, on duty to update and dear healthcare provider issues, with the Solicitor General last week responding to the Court’s request for views that certiorari should not be granted. See 2014 WL 7169712 (SG brief). A similar certiorari petition (2014 WL 7185615) has recently been filed in the adverse Pennsylvania Superior Court trio (2013 #-4), which has a significant issue overlap with Teva.
As we predicted, the FDA’s proposal to change the rules to eliminate generic drug preemption didn’t get finalized in 2014. The FDA postposed it to fall 2015. Frankly, we don’t expect it ever to go into effect.
So next stop, 2015. We wish an equally Happy New Year to all our readers on the right side of the “v.”
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Posted By Bexis to Drug and Device Law at 12/31/2014 08:00:00 AM --
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